Findings Reported for FANTOM II Study of Reva Medical's Bioresorbable Scaffold

June 10, 2019—Twelve-month follow-up data from the FANTOM II study were published by Bernard Chevalier, MD, et al online in Circulation: Cardiovascular Interventions.

The purpose of this study was to evaluate the 9-month angiographic and 12-month clinical outcomes of the Fantom sirolimus-eluting bioresorbable coronary scaffold (Reva Medical, Inc.) in a larger patient population. The Fantom incorporates a radiopaque polymer, struts with a thickness of 125 µm, and a crossing profile of 1.35 mm.

The investigators concluded that the Fantom scaffold demonstrated favorable safety and effectiveness performance at 12-month follow-up. They advised that longer-term follow-up is ongoing to examine the late outcomes with this novel device.

The FANTOM II is the initial evaluation of the 24-month outcomes of the safety and performance of the Fantom device. The prospective, multicenter trial enrolled 240 patients with single de novo coronary stenosis with reference vessel diameter of 2.5 to 3.5 mm and lesion length ≤ 20 mm. Investigators assessed major adverse cardiac events through 12-month follow-up.

As summarized in Circulation: Cardiovascular Interventions, angiographic follow-up was performed in consecutive patient cohorts at 6 months (n = 117) and 9 months (n = 123). The results included the following, as defined in the clinical protocol: acute delivery success 97.9% (235/240); acute technical success 95.8% (230/240); acute procedural success 99.1% (228/230); and clinical procedural success rates 99.6% (227/228).

Additionally, the mean in-stent late lumen loss was 0.25 ± 0.40 mm at 6 months and 0.33 ± 0.36 mm at 9 months. In-segment binary restenosis occurred in 2% of patients at 6 months and 7.6% of patients at 9 months. Additionally, major adverse cardiac events and target lesion failure through 12 months occurred in 4.2% of the 240 patients; scaffold thrombosis developed in only one patient (0.4%), reported the investigators in Circulation: Cardiovascular Interventions.